Swiss Drugmaker Starts Testing Its Swine Flu Vaccine on Humans

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Wednesday, August 05, 2009

http://www.foxnews.com/story/0,2933,537067,00.html?test=latestnews

LONDON — Swiss drugmaker Novartis has begun injecting its swine flu vaccine

into people in the company's first human tests, a spokesman said Wednesday.

The vaccine is being tested in a yearlong trial of 6,000 people of all ages in

Britain, Germany and the United States, Novartis spokesman Althoff told The

Associated Press, adding that the vaccine will likely be on the market before

the trial finishes.

A person in Britain became the first to get the swine flu vaccine about 10 days

ago, he said.

Since swine flu was declared to be a pandemic, or global outbreak, by the World

Health Organization in June, pharmaceuticals have been racing to get their

vaccines ready. Last month, Australian drugmaker CSL became the first vaccine

maker to start testing its vaccine in humans in Australia.

" We initiated clinical trials about 10 days ago, " Althoff said.

Half of Novartis' vaccines being tested are grown in chicken eggs, the

traditional way of making flu vaccines, while the other half use a new

cell-based technology.

The trial will test the vaccine's safety and whether one or two shots are

necessary.

" Our assumption is that two doses will be required, " Althoff said.

The vaccines being tested in Europe use an adjuvant, an ingredient used to boost

the body's immune response. In the U.S., however, Novartis is only testing

vaccines without adjuvants, Althoff said.

WHO recommends that countries use vaccines with adjuvants, to stretch the global

supply of swine flu vaccine. However there are no licensed flu vaccines with

adjuvants in the United States.

Once Novartis AG has preliminary data from the trial, they will submit that to

drug regulators including the European Medicines Agency. European and U.S.

regulators have a fast-track process for approving swine flu vaccine, to ensure

it is available before the flu season starts in the fall, when swine flu is

expected to surge.

The European Medicines Agency has previously said swine flu vaccines based on a

pre-approved bird flu vaccine could be licensed within five days, even without

extensive testing in humans.

Last month, WHO reported that the swine flu viruses being used to make the

vaccine were not growing enough of a key ingredient, and said they were only

producing half as much " yield " as regular flu viruses. The agency asked its

laboratory network to produce a new set of viruses for vaccine makers to use.

Althoff confirmed that Novartis is only getting about 30 to 50 percent of the

usual yield it gets from flu viruses to make vaccines. Novartis made its

vaccines with WHO's original set of flu viruses, and hasn't yet started working

with the new viruses.

The low virus yield could mean delays in when countries get their vaccine orders

filled.

More than 35 countries have placed orders with Novartis for swine flu, or H1N1

vaccine, including France, the Netherlands, and Switzerland. The U.S. has

ordered $979 million worth of bulk vaccine and Novartis' adjuvant.

Althoff said the company expected to start shipping vaccine in the last quarter

of 2009 and will continue the deliveries next year.

GlaxoKline PLC, which has orders for 291 million doses of vaccine from

countries including Britain, has not yet started testing its vaccine in humans.

The U.S. has also ordered $250 million worth of vaccine ingredients from Glaxo.

Since swine flu emerged in April, it has killed at least 1,154 people worldwide

and is estimated to have infected millions.

In India on Wednesday, hundreds of anxious people crowded a hospital waiting to

be tested for swine flu. Panic spread in the city of Pune and fights broke out

at the city's top hospital after authorities reported the country's first swine

flu fatality two days ago.